510(k) K964060 ยท FMF Syringe, Piston
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
| Applicant | Travenol Laboratories (Israel) , Ltd., Kiriat Shemona, IL |
| Decision | Substantially Equivalent, Dec 24, 1996 |
| Received | Oct 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964060
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.